Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Area under the ROC curve of biomarkers (from initial sampling) for prognosis of facial motricity recovery at 3 months
研究概览
简要总结
Bell's palsy (idiopathic peripheral facial palsy) is the most common cause of facial palsy, which is related to the inflammation of the facial nerve, possibly induced by herpesvirus reactivation. Its first-line treatment comprises corticosteroids, antiviral therapy and physiotherapy. In most severe cases (grade IV to VI on House-Brackmann scale), facial motricity may remain altered or develop synkinesis or post-paralytic spasm, thus tremendously affecting quality of life. To avoid potential complications, surgical facial nerve decompression could be proposed. To date, however, there are no means to predict if Bell's palsy will evolve with any complications or if the patient will recover entirely. Thus, the invasive facial nerve decompression is equally proposed to subjects who will develop the consequences as well as to subjects able to restore without surgical treatment. This study proposes to search for prognostic blood biomarkers related to the Bell's palsy recovery pattern. Adult patients with severe Bell's palsy will be proposed to have a blood sampling for proteomic analysis in the early stage of the disease. Then 125 biomarkers on a Peptiquant™ kit will be analysed by mass spectrometry, and prognostic biomarkers will be selected regarding to the clinical recovery of Bell's palsy
详细描述
Bell's palsy (idiopathic peripheral facial palsy) is the most common cause of facial palsy, which is related to the inflammation of the facial nerve, possibly induced by herpesvirus reactivation. Its first-line treatment comprises corticosteroids, antiviral therapy and physiotherapy. In most severe cases (grade IV to VI on House-Brackmann scale), facial motricity may remain altered or develop synkinesis or post-paralytic spasm, thus tremendously affecting quality of life. The recovery of Bell's palsy is currently evaluated either by Sunnybrook Facial Grading System, House-Brackmann scale or Chevalier's method. It is nonetheless unpredictable, especially at the early stage of the disease.
If the first-line treatment fails to provide a fast recovery, facial nerve decompression surgery may be proposed. Being rather complex and risky, this technique shows a lower efficiency if delayed from the onset. Surgical indication is based upon clinical and radiological criteria as well as electrophysiological measurements (electromyography - EMG and electromyoneurography - EMNG). EMG and ENMG methods have a somewhat limited predictive value, since 20 to 40% patients with severe Bell's palsy can recover without surgical treatment. Moreover, these measurements are not widely accessible and, in severe cases, they should be performed between 9 and 20 days from the onset. The surgery, in order to increase its success rate, should be performed in maximum 30 days, ideally in 14 days from the onset.
Therefore, diagnostic and treatment of severe Bell's palsy face a double challenge: a narrow time window to provide a diagnostic and therapeutic strategy, and the need of a reliable prognostic methods to exclude the possibility of spontaneous recovery and thus to justify the surgical approach.
Mass Spectrometry assay allows simultaneous detection of numerous proteins, to screen for inflammatory and neurodegenerative biomarkers at acute stage of Bell's palsy. Some of these proteins might appear of a prognostic value and will help to develop more reliable and personalised treatment approach of severe Bell's palsy.
The primary objective of the study is to identify prognostic blood biomarkers related to the facial motricity recovery at 3 months from onset of severe Bell's palsy in adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Bell's palsy (House-Brackmann more or equal to IV)
- •Disease developed between 5 and 15 days before V0 (after initial corticotherapy)
- •18 years and older
排除标准
- •Facial palsy (central or peripheral) of a following cause suspected at V0:
- •Diabetes, syphilis, HIV-1 or HIV-2 infection, Lyme disease, herpes zoster infection of the geniculate ganglion; Inflammatory or immune pathology, acute or chronic; Intracranial, parotid or facial nerve tumor; Craniofacial injury; Other peripheral neuropathy
- •Anti-inflammatoty, immunomodulating, immunosuppressive treatment
- •Contraindications for an MRI scan
- •Contraindications for a standard medical treatment: prednisone 1 mg per kg a day during 5 days and valaciclovir 3 g a day during 7 days
- •Contraindications for or an impossibility of facial physiotheraphy (2 times per week along with everyday self-theraphy)
- •Pregnancy or breastfeeding
- •Participation to another interventional study
- •Patient unaffiliated to French Social Security regime
- •Patients' refusal to consent to participation in the study
- •Person prived of liberty by judicial or administrative decision
- •Person protected by law (under guardianship or curatorship)
- •Person not able to understand the nature, the aim and the methodology of the study
结局指标
主要结局
Area under the ROC curve of biomarkers (from initial sampling) for prognosis of facial motricity recovery at 3 months
时间窗: Visit 0, Visit 1, Visit 2 and Visit 3 (3 months)
"no recovery" group: gain (Visit 3-Visit 0) \<40% on Chevalier score vs. "recovery" group: gain (Visit 3-Visit 0) ≥40% on Chevalier score. Chevalier score is a clinical scale that evaluates the percentage of facial motricity regarding 15 facial muscles.
次要结局
- Biomarkers related to the speed of recovery in the first 3 months(Visit 0, Visit 1, Visit 2 and Visit 3)
- Biomarkers related to the initial severity of Bell's palsy(Visit 0)
- Diagnostic value of selected biomarkers(Visit 0, Visit 1, Visit 2 and Visit 3)